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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
1430 decision street
vista, CA 92081-8553
PMA NumberP910066
Supplement NumberS015
Date Received03/31/2000
Decision Date08/23/2000
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to *remove the following precaution from the summary of safety and effectiveness and professional labeling; "the safety and effectiveness of the spinalogic(r) has only been studied in patients having spinal fusion treatment. The safety and effectiveness of this device in patients receiving instrumentation, which may distort the magnetic field generated by the device and thus produce a less effective treatment, has not been established"; and *modify the following statement i nthe risks and benefits section of the patient labeling from: "the safety and benefit of the spinalogic(r) was not studied for patients who also have metal implants at the spot of their back surgery," to "the spinalogic(r) was not studied for patients who also have metal implants at the spot of their back surgery. ".